Senior Director, Regulatory CMC
Description

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial.  These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.


Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director of Regulatory Affairs CMC will be responsible for assisting with the development and implementation of CMC regulatory strategy and oversight for the company’s drug-device combination products. The Senior Director will be responsible for collaborating with both internal and external partners and maintaining compliance with global regulatory requirements. 


Responsibilities:

  • Serve as a Regulatory CMC Lead on relevant cross-functional teams that require experienced interpretation of applicable FDA/EMA/ICH regulations
  • Responsible for working with the Technical organization to define CMC strategy and content requirements (data, analysis, and documentation) for regulatory submissions in conformance with established requirements
  • Accountable for the management and delivery of all CMC regulatory milestones, such as those related to global investigational drug filings (e.g., IND/CTA /IMPD /GMO), registrational filings (e.g., NDAs, MAA), and responses to health authority questions/requests
  • Lead CMC related interactions with the health authorities including planning, managing preparation of meeting requests and briefing documents and contingency plans, preparing responses to preliminary comments, and interacting with health authorities
  • Partner closely with senior leaders and key stakeholders to help working teams navigate emerging issues and provide regulatory impact assessment on proposed CMC changes
  • Partner with QA for health authority inspections and inspection preparations 
  • Collaborate with Senior Vice President, Regulatory Affairs on department structure, use of consultants, and budget
  • Help shape company vision and contribute to a healthy company culture
Requirements
  • Bachelor’s degree and 10+ years of Regulatory CMC experience
  • Experience with drug-device combination products highly desirable; some device experience is essential
  • Experience throughout product lifecycle, from development through approval, including experience with regulatory agencies including direct experience with the FDA
  • Strong knowledge of FDA regulations, ICH guidelines, GMP practices
  • Ability to work independently to meet aggressive timelines
  • Collaborative team player who enjoys working in a highly dynamic, cross-disciplinary environment

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration, please submit cover letter and CV.